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There are four deviation classification categories:
1. Critical deviation.
2. Major deviation.
3. Minor deviation.
1. Critical Deviation:
=>> Deviation that cloud has a significant impact on the production quality or GMP system.
Examples of critical deviation are given below but are not limited to :
=>> Usage of contaminated raw materials and solvents.
=>> Failure to process step during the manufacturing.
=>> Use of obsolete batch document/test method
=>> Filter integrity failure.
2. Major Deviation:
=>> Deviations that could have a moderate to a considerable impact on product quality or GMP system.
Ex gave below but not limited to:
=>> Machine breakdown during processing.
=>> Mix-ups of cartons of the same product with different strength
3. Minor Deviation:
The deviation will not have any direct impact on the quality of the product or the GMP system.
Examples of minor deviations are given below but are not limited to :
=>> Minor errors in batch records or documents that do not affect the integrity of the date.
=>> Spillage of material during dispensing.
=>> Failure to meet environmental conditions during batch processing
The following flowchart will help you understand the deviation classification process:
PROCEDURE:
=>> All deviation shall be documented, investigated, tracked, and trended and all deviations shall be reported when they occur.
=>> The person who observes the deviations shall inform the immediate supervisor or concerned department head /designee and to quality assurance.
=>> As per the severity of deviation and stage of the process, the process may be stopped for the Initial Assessment
=>> QA shall issue the “deviation control form“at the request of the initiator (concerned department ) by assigning a deviation number.
=>> The initiator shall fill the details (like product/material/ equipment/document / other if any and batch no / A.R. No if applicable etc ) in the deviations control form.
=>> The initiator shall be initial assessment and shall take suitable immediate action according to the nature of the deviation and inform to department head and concerned QA person.
=>> The initial impact assessment shall be done by the observing department head/designee and designated person QA. recommendation for continuation of process / discontinues the process shall be given by the head of department and Head QA of designee.
=>> Based on the nature of deviation, initial assessment and immediate action taken. The Head of initiating department shall approve the deviation for further evaluation of QA.
=>> After approval of deviation from the head of initiating department, the deviation form shall be forwarded to QA for evaluation.
=>> During evaluation designated QA person shall verify whether the deviation is quality relevance or not and whether the deviation is a repeat occurrence or not.
=>> If it is quality relevance, impact shall be assessed on other areas/departments.
=>> And if it is a repeat occurrence, impact assessment shall extend to verify the effectiveness of previous CAPA taken.
=>> After evaluation categorizes deviation into critical, major, or minor based on the evaluation of impacted areas and product quality impact.
=>> If the deviation is categorised as critical or major, a cross functions team comprising of technical experts from different (as per the nature of deviation) shall be formed to investigate the root cause of deviation.
=>> If the deviation is minor, investigated shall be carried out jointly by a designated QA person along with a person from the department where the deviation happened.
=>> Failure investigation and root cause identifications shall be carried out by the investigation team using investigational methodologies.
=>> Upon identification of the root cause of failure, the probable root cause of failure shall be documented.
=>> Corrective actions and preventive actions shall be recommended to prevent the
Reoccurrence of the same.
=>> The deviation including the investigation report (wherever applicable) shall be closed within 30 working days of the date of the initiation. The initiation date is the date of observation of deviation.
=>> If deviations are not closed within the specified timeline initiator shall rise the “period extension request“ As per SOP.
=>> Initiating Department Head shall review the extension request and write a justification for the period of delay with impact assessment.
=>> QA shall assess the impact of delay in action completion and approve/reject the period extension request.
=>> Deviations shall be closed only when all relevant actions in the CAPA long are completed.
=>> Continuous trending of deviations shall be carried out on monthly basis.
=>> QA shall carry out trend analysis for all the deviations in the whole year at the beginning of the next year by using monthly trend data. A copy trend analysis shall be forwarded to the head CQA.
=>> The record retention for all closed deviation and investigation reports shall be not 7 years or as otherwise agreed with the concerned regulatory body. All deviations and investigation reports shall be kept in the custody of QA and QA shall maintain the deviation register.
